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Regulatory Submissions Manager Jobs (NOW HIRING)

Vrtx

Director, Global Submission Management

Boston, MA · Hybrid

$190K - $285K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Provides oversight for a defined portfolio of regulatory submissions, from planning through ... manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

CEDENT

Regulatory Manager

Boston, MA · On-site

You will oversee the preparation and submission of regulatory documents, manage relationships with regulatory agencies, and lead cross-functional teams to support regulatory activities across a ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site +1

$154K - $204K/yr

Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies * Plays a key role in ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages the preparation and submission of formal regulatory meeting requests and briefing packages and coordinates the face-to-face or online meetings with regulatory agencies * Plays a key role in ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

Manages all aspects of regulatory CMC activities, assists in the development of regulatory submission timelines, and ensures execution to meet corporate goals * Responsible for the preparation of all ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · Remote

$153K - $202K/yr

... Manages the preparation and submission of formal CMC-related regulatory meeting requests and briefing packages and coordinates meetings with regulatory agenciesLeads CMC-related FDA meetings and ...

Jobtailor

Regulatory Affairs Manager

Lake Forest, IL · On-site

$130 - $170/hr

Oversee the preparation, review and submission of data and documentation to support regulatory applications, product registrations. * Establishes and manages systems and processes to support ...

Altimmune

Director, US Regulatory Affairs

Morristown, NJ · On-site

$154K - $204K/yr

High-level management of regulatory projects as assigned, assistance in the development of regulatory submission timelines, and ensuring execution to meet corporate goalsOversee the timelines, review ...

Icon plc

Senior Regulatory Project Manager

Reading, PA

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Senior Regulatory Project Manager ICON is a global healthcare intelligence and clinical research ... Leading and managing cross functional submission teams from authoring to dispatch/project goal ...

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Regulatory Submissions Manager information

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How much do regulatory submissions manager jobs pay per year?

As of Aug 20, 2026, the average yearly pay for regulatory submissions manager in the United States is $110,733.00, according to ZipRecruiter salary data. Most workers in this role earn between $77,500.00 and $136,500.00 per year, depending on experience, location, and employer.

What is a regulatory submissions manager?

A Regulatory Submissions Manager is responsible for overseeing the preparation, compilation, and submission of regulatory documents to health authorities to ensure compliance with applicable laws and guidelines. They work closely with cross-functional teams, including regulatory affairs, clinical, and legal departments, to manage timelines and ensure accurate and timely filings. Their role includes maintaining awareness of regulatory requirements, coordinating responses to agency inquiries, and continuously improving submission processes. Effective communication, attention to detail, and knowledge of regulatory guidelines are key skills for success in this role.

What does a regulatory submissions manager do?

As a Regulatory Submissions Manager, your daily responsibilities often include preparing and reviewing regulatory submission documents, coordinating with internal teams (such as clinical, quality, and R&D), and managing submission timelines to ensure compliance with regulatory requirements. You will also track submission progress, respond to agency queries, and maintain up-to-date records of all communications and submission activities. The role may involve managing multiple projects simultaneously and problem-solving to address any regulatory challenges that arise. Regular collaboration with cross-functional teams is key to driving submissions forward smoothly and meeting critical deadlines.

What are the key skills and qualifications needed to thrive as a regulatory submissions manager?

To thrive as a Regulatory Submissions Manager, you need a strong background in regulatory affairs, scientific or technical disciplines, and project management, typically with a relevant bachelor’s or advanced degree. Familiarity with submission management systems such as eCTD, knowledge of FDA, EMA, or other regulatory guidelines, and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Exceptional attention to detail, organization, and strong written and verbal communication skills are vital for coordinating with cross-functional teams and ensuring timely submissions. These skills are essential for managing complex submission processes, maintaining compliance, and supporting successful product approvals.

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Regulatory Submissions Manager jobs near you
Infographic showing various Regulatory Submissions Manager job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, 11% Part Time, and 1% Contract. Highlights an 81% Physical, 2% Hybrid, and 17% Remote job distribution, with an average salary of $110,733 per year, or $53.2 per hour.

Director, Global Submission Management

Vrtx

Boston, MA • Hybrid

$190K - $285K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 13 days ago

Job description

Job Description

General Summary:

The Director, Global Submission Management (GSM) is responsible for the strategic oversight and execution of a portfolio of global regulatory submissions across development and lifecycle programs. This role will manage submissions for developmentstage, lifecycle, regional, and postapproval, as well as supporting activities required to enable, maintain, and advance global product registrations.

This role ensures routine, regional, and lifecycle submissions are delivered efficiently, compliantly, and predictably in alignment with global regulatory strategies and operational objectives. This role partners closely with Major Submission Leads, Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion functions to support coordinated submission planning, execution consistency, and steadystate portfolio throughput.

Key Duties and Responsibilities:

  • Provides oversight for a defined portfolio of regulatory submissions, from planning through submission and closeout
  • Develops and maintains submission plans, timelines, and tracking across multiple programs
  • Ensures consistent application of submission management standards, tools, and processes
  • Partners with Global Regulatory Strategy, Regulatory CMC, Labeling, Publishing, and Advertising & Promotion to define submission scope, milestones, and deliverables
  • Coordinates crossfunctional activities to ensure submission completeness, quality, and compliance
  • Identifies, manages, and resolves operational risks affecting submission timelines or quality
  • Oversees preparation of submission status updates, issue logs, and portfoliolevel reporting
  • Supports workload planning and capacity management across the submission portfolio
  • Escalates risks appropriately when submissions approach higherimpact or highercomplexity thresholds
  • Leads, coaches, and supports submission management staff including vendor functional service providers (FSPs)
  • Contributes to continuous improvement, knowledge sharing, and talent development within submission management
  • Demonstrates the ability to effectively adopt and leverage emerging technologies, including AI driven tools, and maintains a continuous learning mindset to strengthen GSM decision-making and operational efficiency
  • Proactively remains up to date on advances in technology, AI, automation, competitive intelligence and changes in the Regulatory environment.

Knowledge and Skills:

  • Strong knowledge of global regulatory submission requirements, processes, and timelines
  • Experience with submission and project management tools and systems
  • Ability to manage multiple concurrent submissions and competing priorities
  • Strong organizational, planning, and problemsolving skills
  • Effective stakeholder management and crossfunctional communication skills
  • Ability to drive execution consistency, compliance, and operational efficiency

Education and Experience:

  • Bachelor's degree in Life Sciences, Regulatory Affairs, Project Management, or a related discipline
  • 10+ years of relevant experience with demonstrated leadership across submission portfolios
  • Experience managing routine, regional, and lifecycle regulatory submissions across multiple regions
  • Experience working effectively in matrixed, crossfunctional environments
  • Peoplemanagement experience
  • Experience using modern project management and regulatory submission tooling including MS Project, Smartsheet, and Veeva RIM

Pay Range:

$190,400 - $285,600

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

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